Testimonials
Helping our clients succeed with effective and supportive partnerships
Companies We've Worked With
What Our Clients Say
“Chamow & Associates has made a significant impact on our therapeutic antibody program in taking responsibility for much of our early stage CMC development. Partnering with them has enabled us to remain focused to deploy our in-house resources in other areas until later in clinical development.”
"We had ambitious timelines for the development of our humanized monoclonal antibody, PTX-35, and needed competent technical and regulatory support for our IND submission. Based on their thorough review of all documentation generated by our CDMOs, the experienced consultants at Chamow & Associates generated a gap analysis and crafted a cohesive and accurate Module 3 CMC section for us. Their work was performed in a timely fashion in accordance to our tight deadlines, resulting in a document that allowed us to meet our corporate timeline for IND filing. In the midst of providing regulatory support, Chamow & Associates also was essential in the rescue and re-direction for a key step in drug product formulation and production for this program."
“ITB has a very pleasant and productive collaboration with Chamow & Associates. They have helped us develop and establish biopharmaceutical processes at CMO’s, and are essential when it comes to delivering our projects on time with the right quality. The consultants at Chamow & Associates perform above and beyond our expectations and we are very grateful for all their work.”
“We enjoyed our interactions. You challenged us, you listened to us, you benchmarked us and you helped us to revisit our assumptions. We are implementing several of your recommendations.”
“In order to initiate pivotal clinical studies, we partnered with Chamow & Associates to help prepare and implement our manufacturing strategy for commercial grade drug substance. Their knowledgeable consultants played key roles in the assessment and selection of a suitable CDMO. We have also utilized their project management expertise to coordinate our CMC, QA and regulatory teams. Thanks to their sound planning for CMC, our clinical development program has advanced on schedule and on budget.”
“Over three years working with us, Chamow & Associates has consistently demonstrated excellence in both the business and the science of bringing complex biologics to the clinic. As timeline and scope of development shifted, Steve and his team helped identify solutions that ensured the success of our project. For a small company outsourcing its clinical manufacturing to contract vendors, Chamow & Associates is an invaluable partner in delivering products to patients."
“With our very limited expertise in product development and manufacturing, we started working with Chamow & Associates when Teneobio was a small start-up biotechnology company. They guided us throughout the process from CMO evaluation, process and analytical development to a successful GMP campaign. Their extensive knowledge and background in all aspects of CMC and hands-on approach were crucial for our first and timely IND submission. Steve Chamow has assembled a team of skilled experts on which we continue to rely for advice in other areas such as Quality Assurance and Formulation. I highly recommend Chamow & Associates as a consulting resource for the manufacturing of biopharmaceutical products.”
“Our company needed to adapt from a single reference program used during early development to a two-tiered reference standard. Chamow & Associates assembled a team of expert Manufacturing and Quality Control consultants to guide us through the entire process, providing a solid statistical approach for our cell-based potency assay. Their substantial analytical work allowed us to establish the new reference standard range, and Chamow & Associates further supported these findings with impressive graphics for our annual report needed for requalification. As a result of their knowledgeable insight and comprehensive services, we successfully established both the qualification and requalification procedures in protocols that were submitted to FDA and did not have to address any subsequent issues.”
Director, CMC and Non-Clinical Development
A Commercial-Stage Biotech Company